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Dyne Therapeutics

Director, QA GMP Operations

Waltham, MA · On-site

$188K - $230K/yr

The Director of QA GMP Operations is responsible for management of GMP quality within our external manufacturing operations globally and internal GMP operations for development and commercial ...

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How much do qa gmp jobs pay per hour?

As of Aug 9, 2026, the average hourly pay for qa gmp in the United States is $23.19, according to ZipRecruiter salary data. Most workers in this role earn between $17.55 and $24.28 per hour, depending on experience, location, and employer.

What is the difference between Qa Gmp vs Quality Assurance Specialist?

AspectQa GmpQuality Assurance Specialist
CertificationsGMP training, QA certificationsQA certifications, GMP knowledge often preferred
Work EnvironmentPharmaceutical, biotech, or medical device manufacturingVarious industries including pharma, food, and manufacturing
Employer & Industry UsageRegulated industries with strict compliance standardsBroadly used across multiple industries requiring quality assurance
Search & Comparison IntentUnderstanding GMP-specific QA rolesGeneral QA roles with GMP considerations

Qa Gmp professionals focus specifically on ensuring compliance with Good Manufacturing Practices in regulated industries like pharmaceuticals and biotech. Quality Assurance Specialists may work across various sectors, applying quality standards including GMP. While both roles require similar certifications and work in quality environments, Qa Gmp roles are more specialized in GMP compliance, whereas Quality Assurance Specialists have broader responsibilities across industries.

What is a QA GMP?

QA GMP jobs refer to positions in Quality Assurance (QA) that focus on ensuring compliance with Good Manufacturing Practices (GMP) in industries such as pharmaceuticals, biotechnology, and food production. Professionals in these roles are responsible for monitoring processes, conducting audits, and maintaining documentation to ensure that products are consistently produced and controlled according to quality standards. They play a critical role in safeguarding consumer safety and ensuring regulatory compliance. QA GMP specialists often coordinate with other departments to implement quality systems and handle non-conformances.

What skills and qualifications are needed to thrive as a QA GMP professional?

To thrive as a QA GMP professional, you need a solid understanding of GMP regulations, quality systems, and a background in life sciences or a related field. Familiarity with quality management software, audit tools, and regulatory documentation systems is typically required. Attention to detail, problem-solving abilities, and strong communication skills set outstanding candidates apart. These skills ensure compliance with regulatory standards, safeguard product quality, and support efficient manufacturing operations.

What are common challenges faced by QA GMP professionals in maintaining compliance within a manufacturing facility?

QA GMP professionals often encounter challenges such as keeping up with evolving regulatory standards, ensuring consistent documentation practices, and managing cross-departmental communication. They must be vigilant in identifying deviations or non-conformances and work closely with production, engineering, and quality control teams to implement corrective actions. Balancing day-to-day oversight with the need for ongoing training and audits can be demanding, but these activities are essential to uphold product quality and regulatory compliance.
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Infographic showing various Qa Gmp job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 88% Full Time, 3% Part Time, 7% Contract, and 1% Nights. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution, with an average salary of $48,237 per year, or $23.2 per hour.

Director, QA GMP Operations

Dyne Therapeutics

Waltham, MA • On-site

Full-time

Re-posted 17 days ago

Job description

Role Summary:

The Director of QA GMP Operations is responsible for management of GMP quality within our external manufacturing operations globally and internal GMP operations for development and commercial programs. The Director will also work closely with internal business stakeholders as well as internal Quality function to deliver outcomes to advance programs within compliance.  The Director is responsible for oversight of QA activities and ensuring the quality of deliverables within the role's purview.  

This is an onsite role based in Waltham, MA.

 
Primary Responsibilities Include: 

  • Management of external quality operations in support of GMP manufacturing (clinical and commercial) activities. 
  • Manage deviations, OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines. 
  • Review batch records, analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs. 
  • QA support of Tech Transfer and Process Validation activities. 
  • Disposition of GMP batches and interfacing with the Qualified Person (QP). 
  • Change management to ensure proper evaluation of manufacturing and testing related changes by Quality, Regulatory, and Subject Matter Experts. 
  • Manage CDMO performance within Quality Agreement expectations and GMP compliance.  
  • Drive continuous improvement and inspection readiness.  
  • Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are completed at the CDMOs and internally.  
  • Adjudicate on compliance discussions and negotiate any required corrective actions. 
  • Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence. 

Education and Skills Requirements: 

  • Minimum of a BA/BS degree 
  • Minimum of 10+ years of experience in GMP Quality Operations in a clinical late stage and/or commercial biotechnology company 
  • Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority 
  • Experience implementing and utilizing various outsourcing and support models 
  • Experience with disposition of product batches and interfacing with a Qualified Person (QP) 
  • Excellent written and oral communication skills, including well-developed presentation skills 
  • Excellent organizational skills and ability to manage multiple priorities 
  • Strong collaboration and interpersonal skills to effectively interact with internal or external stakeholders at all levels in the organization 
  • General business management knowledge to assess the impact of project decisions on financial and corporate objectives 
  • Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities 
  • Embrace Dyne's core values and culture 

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